Hengrui’s HRS9531 Wins NMPA Approval for CKD Trial – Dual GIPR/GLP-1R Agonist Expands Beyond Diabetes and Obesity
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS9531, a novel dual...
Drug
Bristol-Myers Squibb’s Sotyktu Wins FDA Label Extension – TYK2 Inhibitor Expands to Psoriatic Arthritis
Bristol-Myers Squibb (BMS, NYSE: BMY) announced FDA approval for a label extension of Sotyktu (deucravacitinib),...
Hengrui’s Adebrelimab Wins NMPA Approval for Two Perioperative Cancer Trials – PD-L1/CTLA-4 Combo Targets Rectal and Gastric/GEJ Cancers
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance for two pivotal...
Leads Biolabs’ Opamtistomig Enters Phase II in First-Line Esophageal Cancer – PD-L1/4-1BB Bispecific with BTD/ODD Designations
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced first patient enrollment in a Phase II...
CSPC’s SYH2059 Inhalation Powder Wins FDA IND Approval – PDE4B Inhibitor Targets Pulmonary Fibrosis with Enhanced Delivery
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced FDA clearance to initiate a clinical study for...
Haisco’s HSK39297 NMPA Filing Accepted – Oral Factor B Inhibitor Targets Paroxysmal Nocturnal Hemoglobinuria Market
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...
CF PharmTech Wins NMPA Approval for Olopatadine Mometasone Combo Trial – Fixed-Dose Nasal Spray Targets Moderate-to-Severe Allergic Rhinitis
CF PharmTech Inc. (HKG: 2652) announced NMPA clearance to initiate a clinical study for its...
Dongcheng Pharma Doses First Patient in 225Ac-LNC1011 Phase I/II Trial – PSMA-Targeted Alpha Radiotherapy for Metastatic Prostate Cancer
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced first subject enrollment in a Phase...
Bio-Thera Wins NMPA Approval for BAT8008 BAT1006 Trastuzumab Combo Trial – Dual HER2 Trop2 Targeting in Advanced Solid Tumors
Bio-Thera Solutions Ltd (SHA: 688177) announced NMPA clearance to initiate a clinical study evaluating BAT8008...
Novo Nordisk’s IcoSema Wins NMPA Approval – Once-Weekly Insulin-Semaglutide Combo Targets China Type 2 Diabetes Market
Novo Nordisk A/S (NYSE: NVO) secured NMPA approval for IcoSema, a once-weekly fixed-dose combination of...
Roche’s Petrelintide Hits 10.7% Weight Loss in Phase II ZUPREME-1 Trial – Amylin Analog Shows Sustained Efficacy Through Week 42
Roche (SWX: ROG, OTCMKTS: RHHBY) announced positive topline results from the Phase II ZUPREME-1 trial...
Sciwind’s Ecnoglutide Wins NMPA Approval for Weight Loss – World’s First cAMP-Biased GLP-1 Agonist Targets China Obesity Market
Sciwind Biosciences announced that Ecnoglutide injection (Xianweiying), the world’s first cAMP-biased GLP-1 receptor agonist, has...
Roche’s Xofluza Wins NMPA Approval for Pediatric Expansion – Oral Suspension Cleared for Children Under 5 Years
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that Xofluza (baloxavir marboxil) has received expanded NMPA approval...
J&J’s TECVAYLI Wins FDA Approval in Earlier-Line Myeloma – BCMA BiTE Plus Daratumumab Combo Expands Addressable Market
Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA)...
Fosun Pharma’s HLX97 Wins NMPA Phase I Approval – First-in-Class KAT6A/B Inhibitor Targets Advanced Solid Tumors
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA: 600196, HKG: 2196) announced that HLX97,...
Insilico Medicine’s AI-Driven ISM4808 Hits Phase I Milestone – TaiGen Doses First Subject in CKD Anemia Trial
Insilico Medicine (HKG: 3696) announced that ISM4808, an AI-driven PHD inhibitor for chronic kidney disease...
HutchMed Initiates Phase I/IIa Trial for HMPL-A580 – Second Antibody-Targeted Triggered Conjugate Targets EGFR+ Solid Tumors
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase I/IIa clinical...
AbbVie’s SKYRIZI Hits AFFIRM Study Endpoints in Crohn’s Disease – 55% Clinical Remission vs. 30% Placebo at Week 12
AbbVie Inc. (NYSE: ABBV) announced positive topline results from the Phase 3 AFFIRM study evaluating risankizumab...
Ab&B Bio-Tech Wins FDA IND Approval for mRNA Mpox Vaccine – China’s First U.S.-Cleared Candidate Targets Immunocompromised Populations
Ab&B Bio-Tech CO., LTD. JS (HKG: 2627) announced that the U.S. Food and Drug Administration...
Novo Nordisk’s CagriSema Fails Non‑Inferiority Test Against Lilly’s Zepbound in Phase III REDEFINE 4 Trial – 23% vs. 25.5% Weight Loss
Novo Nordisk A/S (NYSE: NVO) announced that its Phase III REDEFINE 4 study (NCT06131437) failed...